The Effects of Different Modalities of Exercise in Patients With Schizophrenia

Comparison of Three Different Exercise Training Modalities (Aerobic, Strength, and Mixed) in Patients With Schizophrenia: Study Protocol for a Multi-centre Randomised Wait-list Controlled Trial

Introduction: Numerous studies support the practice of different physical exercise modalities as an effective treatment to address the different problems associated with schizophrenia, reporting that they result in significant improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia.

Ethics and dissemination: This study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia in Spain (reference number: CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained from every participant. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Experimental-Strength training; Other: Experimental-Aerobic training; Other: Experimental-Strength/Aerobic training

Detailed Description

The aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia.

A multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting one hour each, or to the wait-list control group. The training groups will complete aerobic, strength, or mixed (aerobic + strength) training. The participants will be assessed before, immediately after, and 6 months after the end of the intervention. All the patients in the wait-list control group (n = 15) will receive one of the three trainings immediately after the intervention. The study variables will include positive symptomatology, negative symptomatology, and general symptomology (using the Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form), and quality of life (abbreviated World Health Organization Quality of Life questionnaire).

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura García Garcés, Dr.; Phone Number: 64352 96 136 90 00; Email: lauragarciagarcesphd@gmail.com
• Study Contact Backup: Name: María Inmaculada Sánchez López, Dr; Phone Number: 64535 96 136 90 00; Email: maria.sanchez6@uchceu.es

Study Locations

• Spain
  • Valencia, Spain, 46115
    • Universidad CEU-Cardenal Herrera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Schizophrenia
• Age between 18-65 years

Exclusion Criteria:

• Patients with other mental diseases
• Patients with mental disabilities
• Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength training; Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups.	Other: Experimental-Strength training; Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups
Experimental: Aerobic training; Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking,	Other: Experimental-Aerobic training; Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking.
Experimental: Strength/Aerobic training; Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups	Other: Experimental-Strength/Aerobic training; Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups.
No Intervention: Control Group; All the patients in the wait-list control group will receive one of the three trainings immediately after the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Syndrome Scale (PANSS)	Symptoms of schizophrenia are measured according to the subscale scores and total score on the PANSS which consists of 30 items scored from 1 (Absent) to 7 (Extreme). Scores range from 30 to 210, with higher scores indicating more symptoms	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life-Short version (WHOQOL-BREF)	The WHOQOL-BREF contains 24 questions covering 4 domains plus two questions related to overall quality of life and satisfaction with health. Highes scores represent higher quality of life.	16 weeks
Body Mass Index (BMI)	The BMI is defined as the body mass divided by the square of the body height.	16 weeks

Collaborators and Investigators

• Sponsor: Cardenal Herrera University

Publications and helpful links

General Publications

• Garcia-Garces L, Lacamara Cano S, Cebolla Melia Y, Sanchez-Lopez MI, Marques Azcona D, Lison JF, Peyro-Gregori L. Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial. BMJ Open. 2021 Sep 17;11(9):e046216. doi: 10.1136/bmjopen-2020-046216.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: UNIVERSITY UCH-CEU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual deidentified participant data will be available to other researchers.
• IPD Sharing Time Frame: Inmediately following publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No